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Thyroid CancerPhase 2iPRIMENCT03360890

Pembrolizumab With Chemotherapy for Poorly Chemo-responsive Thyroid and Salivary Gland Tumors

A Phase 2 study testing Pembrolizumab and Docetaxel in people with Thyroid Cancer and Salivary Gland Cancer, run by University of Chicago at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Phase II, 2-cohort, single arm trial treated with the combination of the following two agents: 1. Pembrolizumab (MK3475) 200mg, every three weeks, iv 2. Docetaxel 75mg/m2, every three weeks, iv Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer, Salivary Gland Cancer
What is being tested?
Pembrolizumab and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteUnited States
Study dates
26 Mar 2018to Sep 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically confirmed disease that is unresectable and not amenable to curative intent therapy:
  • Cohort A: salivary gland cancers (mucoepidermoid carcinoma, adenocarcinoma, adenoidcystic carcinoma, acinic cell carcinoma, or other histology) originating in salivary glands.
  • Cohort B: thyroid cancer, RAI-refractory and after failure, intolerance to or refusal of anti-antiangiogenic therapy, or with evidence of dedifferentiated or anaplastic histology.
  • ECOG performance status 0 or 1.
  • Consent to undergo on treatment biopsy if tumor is accessible and safe to biopsy
  • Measurable disease per RECIST 1.1, bone only metastatic disease may be allowed on approval from study PI.
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  • Life expectancy of greater than 12 weeks.
  • Available tissue for PD-L1 staining (archival or new core needle biopsy at baseline if no archival tissue available). A minimum of 10 slides are required (unless approval from the PI is obtained)
  • Age greater than or equal to 18 years on day of signing informed consent.
  • Demonstrate reasonable organ function as defined in Table 1, all screening labs should be performed within 10 days of treatment initiation.
  • System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1,500 /mcL Platelets ≥100,000 / mcL Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment) Renal Serum creatinine OR ≤1.5 X upper limit of normal (ULN) OR Measured or calculateda creatinine clearance ≥40 mL/min for subject with creatinine levels > 2.0 X (GFR can also be used in place of creatinine or CrCl) institutional ULN
  • Hepatic Serum total bilirubin ≤ 1.2 X ULN OR in case of Gilbert's disease an elevated total Bilirubin is allowed if direct Bilirubin is ≤40% of total AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN
  • Coagulation International Normalized Ratio (INR) or ≤1.5 X ULN unless subject is receiving anticoagulant therapy Prothrombin Time (PT) as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • aCreatinine clearance should be calculated per institutional standard.
  • Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours of receiving first dose of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  • Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Abstinence is considered an acceptable method of contraception.

Who cannot join

  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks of the first dose of treatment.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy in excess of prednisone 10mg/24h equivalent, or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Has a known history of active TB (Bacillus Tuberculosis)
  • Has hypersensitivity to pembrolizumab, docetaxel or any of its excipients.
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 3 weeks prior to study Day 1, or targeted small molecule therapy within 2 weeks prior to study Day 1, or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier, with the exception of lymphopenia or asymptomatic aberrancies of sodium, amylase, lipase or alkaline phosphatase.
  • Has not recovered from prior surgery, chemotherapy or radiation therapy from adverse events due to a previous treatment/administered agent (i.e., ≤ Grade 1 or return to baseline prior to treatment).
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  • Note: Subjects with ≤ Grade 2 neuropathy, any grade hearing loss or tinnitus, or typical side effects from radiotherapy are an exception to this criterion and may qualify for the study.
  • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical or other cancers that are not likely to influence life expectancy in the subsequent 3 years without active treatment (e.g. low grade prostate cancer in absence of therapy).
  • Has known active (growing) central nervous system (CNS) metastases and/or carcinomatous meningitis. Prior radiation or resection is acceptable if clinically stable for at least 4 weeks.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids in excess of prednisone 10mg/24h equivalent or immunosuppressive drugs) and would represent significant morbidity risk in judgement of investigator. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Has known history of, or any evidence of, active non-infectious pneumonitis.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV 1/2 antibodies). Patients with treated HIV, as evidenced by stable CD4 > 200 for at least 6 months, are eligible.
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  • Has received a live vaccine within 30 days of planned start of study therapy.
  • History of organ transplant that requires use of immunosuppressives.
  • Any condition that would jeopardize the safety of the subject or compliance with the Protocol.
  • Clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed within 30 days prior to initiation of treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: Synergy of Pembrolizumab Anti-PD-1 Immunotherapy With Chemotherapy for Poorly Chemo-responsive Thyroid and Salivary Gland Tumors. The iPRIME Study.

Phase II, 2-cohort, single arm trial treated with the combination of the following two agents:

  1. Pembrolizumab (MK3475) 200mg, every three weeks, iv
  2. Docetaxel 75mg/m2, every three weeks, iv
Read the detailed description

Eligible patients will be divided into two cohorts.

Cohort 1: salivary gland tumors without SOC treatment option Cohort 2: 'aggressive' thyroid cancer without SOC treatment option

Both cohorts will undergo a biopsy and will begin immunotherapy plus chemotherapy. Pembrolizumab and steroid sparing taxane: docetaxel will be given every three weeks for 3 to 6 cycles. For accessible tumors only, at week three patients will receive an on-treatment biopsy.

Patients will move on to immunotherapy maintenance after completing their cycles. Pembrolizumab will be given every three weeks until disease progression or up to 35 cycles (about 2 years).

Keywords
thyroid cancer, salivary gland cancer, pembrolizumab, docetaxel
Medical subject headings
Thyroid Neoplasms, Salivary Gland Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called Keytruda

    Pembrolizumab will be administered via IV at 200mg every three weeks. Patients will receive pembrolizumab for about 2 years.

  • DocetaxelDrug

    Also called taxotere

    Docetaxel will be administered via IV at 75mg/m2 every three weeks for 3 to 6 cycles.

Study groups in NCT03360890
Study groupRoleWhat they receive
Cohort 1: salivary gland tumors without SOC treatment optionExperimentalAll patients will receive pembrolizumab and docetaxel. First pembrolizumab and docetaxel will be given together. After which patients will receive pembrolizumab alone until disease progression or up to 35 cycles (about 2 years).
Receives: Drug: Pembrolizumab; Drug: Docetaxel
Cohort 2: 'aggressive' thyroid cancer without SOC treatment opExperimentalAll patients will receive pembrolizumab and docetaxel. First pembrolizumab and docetaxel will be given together. After which patients will receive pembrolizumab alone until disease progression or up to 35 cycles (about 2 years).
Receives: Drug: Pembrolizumab; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of response

    Measured: From the start of treatment until the first documented record of response, up to 100 months, whichever comes first.

Secondary outcomes (3)

  1. Number of adverse events

    Measured: Up to 24 months.

  2. Overall rate of survival

    Measured: From the start of treatment until the first record of death by any cause, up to 100 months, whichever comes first.

  3. Rate of progression free survival

    Measured: From the start of treatment to the first record of disease progression or death by any cause, up to 100 months, whichever comes first.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2017
  2. Study start26 Mar 2018
  3. Primary completion5 Dec 2025
  4. Study completionSep 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03360890
Sponsor's protocol ID
IRB17-0994
Acronym
iPRIME
Status last verified
Mar 2026
First submitted
20 Nov 2017
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and Docetaxel in people with Thyroid Cancer and Salivary Gland Cancer, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of response (time frame: From the start of treatment until the first documented record of response, up to 100 months, whichever comes first.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03360890.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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